Aelis Farma announced to have reached a key milestone by successfully completing the recruitment of 333 patients suffering from cannabis addiction in its Phase 2b clinical study with AEF0117. AEF0117 is the first of a new class of proprietary drugs developed by Aelis Farma, the Signaling Specific inhibitors of the CB1 receptor of the endocannabinoid system (CB1-SSi). The ongoing multicenter Phase 2b study aims to demonstrate the effectiveness of this "first-in-class" compound in treating cannabis addiction, currently defined as CUD (Cannabis Use Disorder) in the DSM-5, the reference diagnostic manual of mental disorders.

The recruitment and randomization of the 333 study patients were accomplished across 11 clinical centers in the United States, under the coordination of Pr. Frances Levin from Columbia University (New York). The double-blind, placebo-controlled trial involves the administration of either placebo or one of the three tested doses of AEF0117 (0.1 mg, 0.3 mg, and 1 mg) once daily for 3 months.

The primary objective of the study is to assess whether AEF0117 reduces cannabis consumption by demonstrating an increase in the proportion of subjects consuming cannabis =1 day per week compared to the placebo. The proportion of patients achieving other levels of reduced consumption, along with the potential improvement in their quality of life, will also be examined as secondary endpoint. Initial results are expected in line with the timeline previously announced for the second quarter of 2024.

To ensure a smooth transition of AEF0117 to the Phase 3 study after a positive Phase 2b, Aelis Farma initiated, in parallel with the Phase 2b, a series of toxicology studies required by the regulatory authorities. Announced last November, the favourable safety profile observed in this context validates the positive observations of the independent Data Safety Monitoring Board (DSMB) for the initial 115 patients in the Phase 2b study, confirming the good tolerance of AEF0117 in individuals with cannabis addiction. Thanks to the completion of these non-clinical developments ahead of schedule, AEF0117 will be ready to enter the Phase 3 clinical study for cannabis addiction at the end of a positive Phase 2b, subject to regulatory approval of the Phase 3 design.

The Phase 2b study is an integral part of the clinical program for AEF0117, which received USD 7.8 million of total funding from the National Institutes of Health (NIH), with USD 4.5 million allocated in late 2021 for the current development phase. Previously, a Phase 2a study, conducted by Pr. Margaret Haney (Columbia University, NY) in volunteers with cannabis addiction, provided initial evidence of the efficacy of AEF0117 with a favourable safety profile.

Based on encouraging Phase 2a results, Aelis Farma entered into an exclusive option and license agreement in 2021 with Indivior PLC, a leading pharmaceutical group in addiction treatment, for the development and commercialization of AEF0117 as a treatment for disorders due to excessive cannabis use. As part of this agreement, Aelis Farma has received already USD 30 million (option payment). If Indivior exercises the license option at the end of the Phase 2b (H2 2024), Aelis Farma will receive a USD 100 million license fee and up to USD 340 million in additional payments contingent on the achievement of development, regulatory and commercial milestones as well as, royalties on net sales of AEF0117 ranging between 12% and 20%.

Following the exercise of the option, all development, registration, and commercialization costs of AEF0117 will be borne by Indivior.